System to Accelerate Clinical Development
We are committed to promoting clinical development with enthusiasm to deliver new drugs as soon as possible that meet the needs of people suffering from diseases throughout the world.
To create development plans and trial designs with the aim of obtaining marketing approval in the shortest time, we work to properly understand unmet medical needs by analyzing target diseases multilaterally. We also take part in activities with the Discovery and Research Division to reduce the period from commencement of drug discovery to demonstration of drug discovery concepts (POC establishment) in humans. In addition, we are speeding up collecting the data required for completing applications for marketing approval in Japan, South Korea, and Taiwan by conducting multinational clinical trials and advancing mutual use of results from overseas studies with our partners.
Progress Status of Promotion of Clinical Development
Currently, we have almost as many as 100 clinical trials ongoing mainly in the oncology domain, one of our key strategic areas. In clinical development in the oncology domain, we are progressing investigation of biomarkers and combination therapies as a pioneer in cancer immunotherapy to provide patients with better treatment options.
Our development organization handles two domains: oncology and primary care. In the oncology domain, we have a system in place to accelerate development from phase I to marketing approval. In the primary case domain, we have an organizational structure per disease domain to enhance disease expertise. We also have a system that can accelerate implementation of POC establishment and validation study, so as to accurately meet the needs of frontline healthcare as soon as possible.
Global Clinical Development System
Establishment of Development Systems in the US and Europe by Setting Up Local Centers
In addition to Japan, South Korea, and Taiwan, we have established development organization in U.S. and Europe, and have been conducting clinical studies on a global basis, aiming to obtain approval globally.
In the US and Europe, our local subsidiaries, ONO PHARMAUSA, INC. (OPUS) and ONO PHARMA UK LTD. (OPUK), will pursue organizational improvements that enable us to, in addition to early-stage clinical trials, conduct late-stage clinical trials in the US and Europe and apply for approval with the regulators.